FDA Device recall Z-0418-2021
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular syste…
- FDA Device
- Class II
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular syste… by Angiodynamics, citing 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0418-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-14 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Angiodynamics |
| Distribution | US |
Product
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
Reason
5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
Identifiers
| code_info | Lot Number: 5626935 Expiration Date: 08/31/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0418-2021%22
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